A Phase 2, Double-blind, Randomized, Placebo controlled Study to Evaluate the Effects of Sotatercept versus Placebo for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) due to Heart Failure with Preserved Ejection Fraction (HFpEF)

Date Added
April 12th, 2022
PRO Number
Pro00119299
Researcher
Daniel Silverman

List of Studies

Keywords
Heart, Pulmonary Hypertension, Shortness of Breath
Summary

The purpose of the study is to evaluate the safety and how well the medication sotatercept works versus placebo in treating Heart Failure with a Preserved Ejection Fraction. The study will also look at information obtained from the tests performed as part of the study to see if subjects have improvement in symptoms of heart failure. Participation in this study will last approximately 26 months. During the study period subjects will be asked to attend regular study visits with the research coordinator. These visits will include such activities as blood tests, questionnaires, physical evaluation by a study doctor, a right heart catheterization with exercise, echocardiogram, and 6 minute hall walks. There will be 35 visits as part of participation in this clinical trial.

Participants will be randomized to either the treatment group (and receive the medication) or the control group (and not receive the medication). Subjects will have a 66:33 chance of receiving the study medication during their participation in the trial. The treatment assignment is determined by randomization, where a computer selects at random which treatment group you will be in (like drawing straws). Neither the subject, nor the blinded personnel will know which group subjects are in. Neither the subject nor the study doctor will decide what group subjects are assigned.

Institution
MUSC
Recruitment Contact
Melissa Lamicq
843-876-5783
lamicq@musc.edu

A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Depemokimab in Adults with Hypereosinophilic Syndrome (HES)

Date Added
May 3rd, 2022
PRO Number
Pro00119532
Researcher
Kelli Williams

List of Studies


Keywords
Blood Disorders, Rare Diseases
Summary

The purpose of this study is to see if taking depemokimab is safe and effective in treating Hypereosinophilic syndrome (HES) in adults (≥18 years) with uncontrolled HES receiving standard of care (SoC) therapy. The study will last approximately 52 weeks and is a placebo-controlled, double blind, multicentre study.

Institution
MUSC
Recruitment Contact
Natalie Naylon
843-792-5824
naylon@musc.edu

A Phase 2/3 Adaptive, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of VX-147 in Adult and Pediatric Subjects with APOL1-mediated Proteinuric Kidney Disease

Date Added
May 11th, 2022
PRO Number
Pro00117678
Researcher
Roberto Pisoni

List of Studies


Keywords
Drug Studies, Genetics, Kidney, Minorities, Rare Diseases
Summary

This randomized, double-blind, placebo-controlled Phase 2/3 adaptive study involves an initial investigational blood test to determine if you have a specific variation related to kidney disease. The investigational blood test is to see if you have changes in your DNA of a gene called APOL1. People who have this gene variation may be at risk of losing their kidney function faster than others. If you have the variants (changes in DNA) you may be eligible to continue participation in the study. If you do not have the variants, you will not be eligible, and the study doctor will discuss your other options with you. If you decide to participate, there will be no cost to you and you will be compensated. This study will start by comparing two doses of VX-147 against placebo in subjects with APOL1-mediated kidney disease for 12 weeks. Subjects in Phase 2 will continue to Phase 3 once a dose for Phase 3 is selected. Then the Phase 3 dose of VX-147 will be evaluated for safety and effectiveness. If you meet the requirements and choose to take part in the study, you will be randomly assigned to a treatment group. You will not know which study treatment group you are assigned to and it is possible that you will receive placebo instead of VX-147. The study includes a screening, treatment, and follow-up period. The study will end after the last patient enrolled has completed 2 years in the study. This means some patients enrolling earlier could be in the study for up to 4 years.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu

A SAFETY RUN-IN AND PHASE II STUDY EVALUATING THE EFFICACY, SAFETY, AND IMPACT ON THE TUMOR MICROENVIRONMENT OF THE COMBINATION OF TOCILIZUMAB, ATEZOLIZUMAB, AND FRACTIONATED STEREOTACTIC RADIOTHERAPY IN RECURRENT GLIOBLASTOMA

Date Added
May 12th, 2022
PRO Number
Pro00120398
Researcher
Alicia Zukas

List of Studies

Keywords
Cancer/Brain, Glioblastoma
Summary

This study is for men and women with recurrent glioblastoma. The purpose of the study is to see if adding immune therapy drugs to usual radiation therapy can shrink or stabilize brain cancer.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

Disparities in REsults of Immune Checkpoint Inhibitor Treatment (DiRECT): A Prospective Cohort Study of Cancer Survivors Treated with anti-PD-1/anti-PD-L1 Immunotherapy in a Community Oncology Setting

Date Added
June 22nd, 2022
PRO Number
Pro00121172
Researcher
Albert Lockhart

List of Studies

Keywords
Cancer
Summary

This study is for patients with invasive cancer I-IV and be scheduled to receive anti-PD-1/-L1 ICI-containing therapy. This study is being done to see if we can understand which patients will develop side effects from immune checkpoint inhibitors, and what kind of side effects they will get and can we predict long-term treatment outcomes after immune checkpoint inhibitor treatment, like which patients will have a cancer that shrinks or disappears.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis

Date Added
June 30th, 2022
PRO Number
Pro00121190
Researcher
Christine Holmstedt

List of Studies


Keywords
Stroke
Summary

The purpose of this research study is to see whether ticagrelor and aspirin or rivaroxaban and aspirin compared to clopidogrel and aspirin will have the most success in preventing another stroke, bleed in the brain, or death in participants who have already had a stroke from a narrowed brain artery.

Institution
MUSC
Recruitment Contact
Caitlan LeMatty
8437928606
lemattyc@musc.edu

A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer

Date Added
August 2nd, 2022
PRO Number
Pro00121443
Researcher
Mariam Alexander

List of Studies

Keywords
Cancer, Cancer/Lung, Lung
Summary

This study is for patients who have been diagnosed with advanced non-small cell lung cancer. The purpose of this study is to compare the usual treatment alone to using SBRT plus the usual treatment. This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the addition of SBRT increases the life of patients by 6 months or more compared to the usual approach. The study drugs are nivolumab and ipilimumab. Participants can expect to be on this study for up to 2 years.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence (INDICATE)

Date Added
August 5th, 2022
PRO Number
Pro00122143
Researcher
Harriet Eldredge-Hindy

List of Studies

Keywords
Cancer/Genitourinary, Prostate
Summary

This study is for men with prostate cancer that has come back after surgery. This study is being done to see if PET/CT scans help provide more tailored treatment recommendations and outcomes for men who have prostate cancer after radical prostatectomy (RP) and will adding focal, metastasis directed radiation treatment (e.g.., stereotactic radiation) and/or additional systemic therapy (e.g., apalutamide) to standard of care treatment help to delay progression of prostate cancer in men who have already had an RP and now have recurrence?

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
(843) 792-9321
hcc-clinical-trials@musc.edu

MEPITEL FILM FOR THE REDUCTION OF RADIATION DERMATITIS IN BREAST CANCER PATIENTS UNDERGOING POST-MASTECTOMY RADIATION THERAPY: A RANDOMIZED PHASE III CLINICAL TRIAL

Date Added
August 15th, 2022
PRO Number
Pro00122724
Researcher
Jennifer Harper

List of Studies


Keywords
Cancer/Breast
Summary

This study is for patients who have been diagnosed with breast cancer and their doctor has recommended that they receive radiation therapy after their mastectomy to reduce the risk of their breast cancer coming back. This study is being done to see if the severity of skin redness and peeling in the area of radiation can be reduced by applying Mepitel Film during radiation therapy.

Institution
MUSC
Recruitment Contact
Barbara Roe
843-652-1607
broe@tidelandshealth.org

ACCESS: A Multi-Center, Phase II Trial of HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation with Post-Transplantation Cyclophosphamide for Patients with Hematologic Malignancies.

Date Added
August 16th, 2022
PRO Number
Pro00118834
Researcher
Michelle Hudspeth

List of Studies


Keywords
Adolescents, Cancer, Pediatrics, Transplant
Summary

This study is for patients that have had hematopoietic stem cell transplants and/or have been donors. The purpose of this study is to see how well transplant works in adults with a MMUD using stem cells from a donor's blood, and in children with a MMUD using stem cells from a donor's bone marrow.This study treatment does not include any investigational drugs. The medicines and procedures in this study are standard for transplant. Participants can expect to be on this study for approximately 1 year.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@musc.edu



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